Sara Gerke

Assistant Professor of Law

Sara Gerke joined Penn State Dickinson Law as Assistant Professor of Law in July 2021. Her current research focuses on the ethical and legal challenges of artificial intelligence and big data for health care and health law in the United States and Europe. She also researches comparative law and ethics of other issues at the cutting edge of medical developments, such as the clinical translation of stem cell research, biological products, such as somatic cells, tissues, and gene therapy, reproductive medicine, such as mitochondrial replacement techniques, and digital health more generally.

Professor Gerke is the Co-Principal Investigator of the study of the legal and ethical implications raised by AI-assisted surgery in the interdisciplinary project CLASSICA (Validating AI in Classifying Cancer in Real-Time Surgery). This four-year project is funded by the European Union through the Horizon Europe funding program with a total of €6 million for four years with 11 partners from nine countries. She also spearheads, as Co-Principal Investigator, the study on addressing ethical and legal concerns raised by AI in colonoscopy in the interdisciplinary project OperA (Optimizing Colorectal Cancer Prevention Through Personalized Treatment With Artificial Intelligence). This five-year project consists of 18 partners from 13 countries and received €6 million in funding (i.e., €4.7 million from Horizon Europe and the remainder from a U.K. funding body). Professor Gerke is also a leadership team member of the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Professor Gerke’s work has appeared or is forthcoming in leading law, medical, scientific, and bioethics journals, such as The George Washington Law Review, Yale Journal of Health Policy, Law, and Ethics, JAMA, Science, Nature Medicine, npj Digital Medicine, Nature Machine Intelligence, Nature Biotechnology, The Lancet Digital Health, Journal of Law and the Biosciences, Journal of Law, Medicine & Ethics, Hastings Center Report, and The American Journal of Bioethics, as well as books published by Cambridge University Press, Elsevier, and Springer. She is also the first editor of a stakeholder book on the clinical application of human induced pluripotent stem cells published with Springer in 2020.

Professor Gerke was also recently named a 2021 Health Law Scholar by the American Society for Law, Medicine & Ethics and the Saint Louis University School of Law Center for Health Law Studies.

At Penn State Dickinson Law, Professor Gerke teaches Torts, Health Care Law & Policy, and Food and Drug Law. With her expertise in the ethics and law of AI, big data, and digital health, she has also been frequently invited as a guest lecturer at other schools, such as Harvard Medical School, Harvard T.H. Chan School of Public Health, Massachusetts Institute of Technology, and McGill University, Faculty of Medicine and Health Sciences.

Professor Gerke previously served as a Research Fellow in Medicine, Artificial Intelligence, and Law at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, where she oversaw the day-to-day work of the PMAIL project, including conducting law, policy, and ethics research; drafting reports and recommendations; and coordinating the Center’s efforts with collaborators at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen as well as other partners. Before joining the Petrie-Flom Center at Harvard Law School, Professor Gerke was the General Manager of the Institute for German, European and International Medical Law, Public Health Law and Bioethics of the Universities of Heidelberg and Mannheim (IMGB).

Professor Gerke has presented at several national and international legal, medical, bioethics, and industry conferences organized, for example, by the U.S. Department of Health and Human Services, National Academy of Medicine Leadership Consortium, Harvard Law School, Harvard Business School, Stanford Law School, Boston Bar Association, University of Copenhagen, University of Cambridge, University College London, and the University of Oxford. She has also co-organized a variety of conferences and events, such as Black-Box Medicine: Legal and Ethical Issues and AI and Disability/Dependency: Equity, Access, and Interdependence.

Professor Gerke is a member of several working groups and committees. For example, she is a member of the Advisory Group — Academic — of the American Board of AI in Medicine (ABAIM), a research member (Health Law) of the Z-inspection® Initiative, and a member of the Ethical, Legal, and Social Issues (ELSI) Group of DARPA’s ADvanced Acclimation and Protection Tool for Environmental Readiness (ADAPTER) program. She is also the co-initiator of the ELSI Strategic Working Group at the German Stem Cell Network (GSCN) and a member of Sana Biotechnology’s stem cell research oversight (SCRO) committee.

From April 2016 to March 2018, Professor Gerke was also the Co Investigator of an interdisciplinary project, known as “ClinhiPS,” sponsored by the German Federal Ministry of Education and Research (funds: 657,678.00 EUR). This project analyzed the clinical application of human induced pluripotent stem cells in Germany and Austria from scientific, ethical, and comparative legal perspectives.

Professor Gerke earned a degree in law (Dipl.-Jur. Univ.; J.D. equivalent) in July 2012 from the University of Augsburg with distinction-level results. She also holds a Master’s degree in Medical Ethics and Law from King’s College London (December 2013), and achieved a distinction in her Master’s dissertation entitled “A Market in Human Organs from the Living or an Opt-Out System? A Legal and Ethical Analysis to Identify a Way to Address the Organ Shortage in the United Kingdom”. In addition, she expects her Dr. iur. (Ph.D. in Law equivalent) on the regulation of stem cell research in Europe to be officially awarded from the University of Mannheim in 2022.


Select Publications by Professor Gerke

Sara Gerke, Health AI for Good Rather than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices, 20 Yale Journal of Health Policy, Law, and Ethics 433 (2021, published April 2022). 

Sara Gerke, Digital Home Health During the COVID-19 Pandemic: Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward, in The Future of Medical Device Regulation: Innovation and Protection (I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson & Carmel Shachar eds., Cambridge University Press, 2022).

Sara Gerke, Timo Minssen & I. Glenn Cohen, Ethical and Legal Challenges of Artificial Intelligence-Driven Healthcare, in Artificial Intelligence in Healthcare 295 (Adam Bohr & Kaveh Memarzadeh eds., Elsevier 2020).  

Sara Gerke, Carmel Shachar, Peter R. Chai & I. Glenn Cohen, Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies During COVID-19, 26 NATURE MED. 1176 (2020). 

Sara Gerke, Ariel D. Stern & Timo Minssen, Germany’s Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries, 3 NPJ DIGIT. MED. Article number: 94 (2020).

Sara Gerke, Boris Babic, Theodoros Evgeniou & I. Glenn Cohen, The Need for a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device, 3 NPJ DIGIT. MED. Article number: 53 (2020).  

Sara Gerke, Serena Yeung & I. Glenn Cohen, Ethical and Legal Aspects of Ambient Intelligence in Hospitals, 323 JAMA 601 (2020).

Sara Gerke

Emailsgerke@psu.edu

Phone 717-240-5138

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Faculty Impact


Education

Dipl.-Jur. Univ., University of Augsburg

M.A. in Medical Ethics and Law, King’s College London


Research Interests

Health Law (including bioethics, artificial intelligence, digital health, stem cell research, genetics, reproductive technology, and other health law topics), Food and Drug Law, Privacy Law, Law and Medicine, Law and Technology, and Comparative Law (the U.S. and Europe)


Current Courses
Torts

Health Law

Food and Drug Law

Gerke's Publications

Edited Book

Sara Gerke, Jochen Taupitz, Claudia Wiesemann, Christian Kopetzki & Heiko Zimmermann (eds.), Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen — Ein Stakeholder-Sammelband [The Clinical Application of Human Induced Pluripotent Stem Cells — A Stakeholder Anthology] (Springer 2020).

Journal Articles

Craig M. Klugman & Sara Gerke, Rise of the Bioethics AI: Curse or Blessing? 22 The American Journal of Bioethics 35 (2022).

Carmel Shachar, Sara Gerke, Walker Morrell, Aaron Kirby, I. Glenn Cohen & Barbara E. Bierer, When is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research, 44 Ethics & Human Research 2 (2022). 

Sara Gerke, Health AI for Good Rather than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices, 20 YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS 433 (2021, published April 2022). 

Sara Gerke & Delaram Rezaeikhonakdar, Privacy Aspects of Direct-to-Consumer Artificial Intelligence/Machine Learning Health Apps, 6 Intelligence-Based Medicine 100061 (2022). 

Georgia R. Goodman, Anna Kikut, Maria J. Bustamante, Lizette Mendez, Yassir Mohamed, Carmel Shachar, I. Glenn Cohen, Sara Gerke, Edward W. Boyer, Rochelle K. Rosen, Kenneth H. Mayer, Conall O’Cleirigh & Peter R. Chai, “I’d Feel Like Someone Was Watchin’ Me… Watching for a Good Reason”: Perceptions of Data Privacy, Access, and Sharing in the Context of Real-Time PrEP Adherence Monitoring Among HIV-Negative MSM With Substance Use, AIDS and Behavior (2022).

Kristin M. Kostick-Quenet, I. Glenn Cohen, Sara Gerke, Bernard Lo, James Antaki, Faezah Movahedi, Hasna Njah, Lauren Schoen, Jerry E. Estep & J.S. Blumenthal-Barby, Mitigating Racial Bias in Machine Learning, 50 JOURNAL OF LAW, MEDICINE & ETHICS 92 (2022).

Julia Amann, Dennis Vetter, Stig Nikolaj Blomberg, Helle Collatz Christensen, Megan Coffee, Sara Gerke, Thomas K. Gilbert, Thilo Hagendorff, Sune Holm, Michelle Livne, Andy Spezzatti, Inga Strümke, Roberto V. Zicari & Vince Istvan Madai, To Explain or Not to Explain?—Artificial Intelligence Explainability in Clinical Decision Support Systems, 1 PLOS DIGIT HEALTH e0000016 (2022).

Marc A. Rodwin & Sara Gerke, German Pharmaceutical Pricing: Lessons for the United States, 52 INTERNATIONAL JOURNAL OF HEALTH SERVICES 146 (2022).

Boris Babic, Sara Gerke, Theodoros Evgeniou & I. Glenn Cohen, Beware Explanations From AI in Health Care, 373 SCIENCE 284 (2021).

George Maliha, Sara Gerke, Ravi B. Parikh & I. Glenn Cohen, To Spur Growth in AI, We Need a New Approach to Legal Liability, HARVARD BUSINESS REVIEW (2021).

Roberto V. Zicari, James Brusseau, Stig N. Blomberg, Helle Collatz Christensen, Megan Coffee, Marianna B Ganapini, Sara Gerke, Thomas Krendl Gilbert, Eleanore Hickman, Elisabeth Hildt, Sune Holm, Ulrich Kühne, Vince I. Madai, Walter Osika, Andy Spezzatti, Eberhard Schnebel, Jesmin J. Tithi, Dennis Vetter, Magnus Westerlund, Renee Wurth, Julia Amann, Antun Vegard, Valentina Beretta, Frédérick Bruneault, Erik Campano, Boris Düdder, Alessio Gallucci, Emmanuel Goffi, Christoffer B. Haase, Thilo Hagendorff, Pedro Kringen, Florian Möslein, Davi Ottenheimer, Matiss Ozols, Laura Palazzani, Martin Petrin, Karin Tafur, Jim Tørresen, Holger Volland & Georgios Kararigas, On Assessing Trustworthy AI in Healthcare. Machine Learning as a Supportive Tool to Recognize Cardiac Arrest in Emergency Calls, 3 FRONTIERS IN HUMAN DYNAMICS 673104 (2021).

Sara Gerke, Gali Katznelson, Dorit Reiss & Carmel Shachar, COVID-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations, 49 THE JOURNAL OF LAW, MEDICINE & ETHICS 293 (2021).

Boris Babic, Sara Gerke, Theodoros Evgeniou & I. Glenn Cohen, Direct-to-Consumer Medical Machine Learning and Artificial Intelligence Applications, 3 NATURE MACH. INTELL. 283 (2021).

George Maliha, Sara Gerke, I. Glenn Cohen & Ravi B. Parikh, Artificial Intelligence and Liability in Medicine: Balancing Safety and Innovation, 99 MILBANK Q. 629 (2021).

Gali Katznelson & Sara Gerke, The Need for Health AI Ethics in Medical School Education, 26 ADV. IN HEALTH SCI. EDUC. 1447 (2021).

Boris Babic, I. Glenn Cohen, Theodoros Evgeniou & Sara Gerke, When Machine Learning Goes Off the Rails, HARV. BUS. REV. (2021).

W. Nicholson Price II, Sara Gerke & I. Glenn Cohen, How Much Can Potential Jurors Tell Us about Liability for Medical Artificial Intelligence?, 62 JNM 15 (2021).

I. Glenn Cohen, Sara Gerke & Daniel B. Kramer, Ethical and Legal Implications of Remote Monitoring of Medical Devices, 98 MILBANK Q. 1257 (2020).

Sara Gerke, Carmel Shachar, Peter R. Chai & I. Glenn Cohen, Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies During COVID-19, 26 NATURE MED. 1176 (2020).

Hrefna D. Gunnarsdóttir, Michael S. Sinha, Sara Gerke & Timo Minssen, Applying the Proportionality Principle to COVID-19 Antibody Testing, J. L. BIOSCI. lsaa058 (2020).

Sara Gerke, Ariel D. Stern & Timo Minssen, Germany’s Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries, 3 NPJ DIGIT. MED. Article number: 94 (2020).

I. Glenn Cohen, Theodoros Evgeniou, Sara Gerke & Timo Minssen, The European Artificial Intelligence Strategy: Implications and Challenges for Digital Health, 2 THE LANCET DIGITAL HEALTH E376 (2020).

Carmel Shachar, Sara Gerke & Eli Y. Adashi, AI Surveillance during Pandemics: Ethical Implementation Imperatives, 50 HASTINGS CENT. REP. 18 (2020).

Timo Minssen, Sara Gerke, Mateo Aboy, Nicholson Price & I. Glenn Cohen, Regulatory Responses to Medical Machine Learning, J. L. BIOSCI. lsaa002 (2020).

Sara Gerke, Boris Babic, Theodoros Evgeniou & I. Glenn Cohen, The Need for a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device, 3 NPJ DIGIT. MED. Article number: 53 (2020).

Sara Gerke, Serena Yeung & I. Glenn Cohen, Ethical and Legal Aspects of Ambient Intelligence in Hospitals, 323 JAMA 601 (2020).

I. Glenn Cohen, Eli Y. Adashi, Sara Gerke, César Palacios-González & Vardit Ravitsky, The Regulation of Mitochondrial Replacement Techniques Around the World, 21 ANNU. REV. GENOM. HUM. 565 (2020).

Boris Babic, Sara Gerke, Theodoros Evgeniou & I. Glenn Cohen, Algorithms on Regulatory Lockdown in Medicine: Prioritize Risk Monitoring to Address the “Update Problem”, 366 SCIENCE 1202 (2019).

W. Nicholson Price II, Sara Gerke & I. Glenn Cohen, Potential Liability for Physicians Using Artificial Intelligence, 322 JAMA 1765 (2019).

Mateo Aboy, Kathleen Liddell, Cristina Crespo, I. Glenn Cohen, Johnathon Liddicoat, Sara Gerke, & Timo Minssen, How Does Emerging Patent Case Law in the US and Europe Affect Precision Medicine?, 37 NATURE BIOTECHNOL. 1118 (2019).

Sara Gerke, Timo Minssen, Helen Yu & I. Glenn Cohen, Ethical and Legal Issues of Ingestible Electronic Sensors, 2 NATURE ELECTRON. 329 (2019).

Sara Gerke & Shaun Pattinson, EU Marketing Authorisation of Orphan Medicinal Products and Its Impact on Related Research, 24 EUR. J. HEALTH L. 541 (2017).

Jochen Taupitz, Franz Geisthövel, Dagmar Coester-Waltjen, Helmut Frister, Monika Frommel, Sara Gerke, Benjamin Hermes, Friedhelm Hufen, Alexandra Ochsner, Henning Beier & Christian Thaler, V. Mannheimer Workshop zur Fortpflanzungsmedizin: Ein juristischer Diskurs zur Präimplantationsdiagnostik und Embryonenspende auf der Basis neuerer reproduktionsbiologischer Prämissen [5th Mannheim Workshop on Reproductive Medicine: A Legal Discourse on Preimplantation Diagnosis and Embryo Donation Based on Recent Reproductive Biological Premises], 12 JOURNAL OF REPROD. MED. AND ENDOCRINOL. 42 (2015).

Book Chapters 

Hrefna D. Gunnarsdóttir, I. Glenn Cohen, Timo Minssen & Sara Gerke, The Ethics and Laws of Medical Big Data, in The Cambridge Handbook of Information Technology, Life Sciences and Human Rights (M. Ienca, O. Pollicino, L. Liguori, E. Stefanini & R. Andorno eds., Cambridge University Press, 2022).

Sara Gerke, Digital Home Health During the COVID-19 Pandemic: Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward, in The Future of Medical Device Regulation: Innovation and Protection (I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson & Carmel Shachar eds., Cambridge University Press, 2022).

Timo Minssen & Sara Gerke, Ethische und rechtliche Herausforderungen digitaler Medizin in Pandemien [Ethical and Legal Challenges of Digital Medicine in Pandemics], in Pandemien und Ethik [Pandemics and Ethics] 179 (Andreas Reis, Martina Schmidhuber & Andreas Frewer eds., Springer 2021).

Sara Gerke, Timo Minssen & I. Glenn Cohen, Ethical and Legal Challenges of Artificial Intelligence-Driven Healthcare, in Artificial Intelligence in Healthcare 295 (Adam Bohr & Kaveh Memarzadeh eds., Elsevier 2020).

Sara Gerke, Die klinische Translation von hiPS-Zellen in Deutschland [The Clinical Translation of hiPSCs in Germany], in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 243 (Sara Gerke et al. eds., Springer 2020).

Sara Gerke & Solveig Lena Hansen, Die Klinische Anwendung von hiPS-Zellen: Ein Überblick [The Clinical Application of hiPSCs: An Overview], in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 1 (Sara Gerke et al. eds., Springer 2020).

Sara Gerke, Solveig Lena Hansen, Verena Christine Blum, Stephanie Bur, Clemens Heyder, Christian Kopetzki, Ina Meiser, Julia C. Neubauer, Danielle Noe, Claudia Steinböck, Claudia Wiesemann, Heiko Zimmermann & Jochen Taupitz, Naturwissenschaftliche, ethische und rechtliche Empfehlungen zur klinischen Translation der Forschung mit humanen induzierten pluripotenten Stammzellen und davon abgeleiteten Produkten [Scientific, Ethical, and Legal Recommendations for the Clinical Translation of Research Using Human Induced Pluripotent Stem Cells and Derived Products], in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 459 (Sara Gerke et al. eds., Springer 2020).

Sara Gerke, Christian Kopetzki, Verena Christine Blum, Danielle Noe & Claudia Steinböck, Eine rechtsvergleichende Analyse der klinischen Translation von hiPS-Zellen in Deutschland und Österreich [A Comparative Legal Analysis of the Clinical Translation of hiPSCs in Germany and Austria], in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 421 (Sara Gerke et al. eds., Springer 2020).

Sara Gerke & Jochen Taupitz, Rechtliche Aspekte der Stammzellforschung in Deutschland: Grenzen und Möglichkeiten der Forschung mit humanen embryonalen Stammzellen (hES Zellen) und mit humanen induzierten pluripotenten Stammzellen (hiPS Zellen) [Legal Aspects of Stem Cell Research in Germany: Limits and Possibilities of Research Using Human Embryonic Stem Cells (hESCs) and Human Induced Pluripotent Stem Cells (hiPSCs)], in Stammzellforschung: Aktuelle wissenschaftliche und gesellschaftliche Entwicklungen [Stem Cell Research: Current Scientific and Social Developments] 209 (Martin Zenke, Lilian Marx-Stölting & Hannah Schickl eds., Nomos 2018).